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Asthma | Azithromycin for Children Hospitalized With Asthma

Asthma research study

What is the primary objective of this study?

Asthma is a chronic lung condition in children, and often requires hospitalization for acute exacerbations. Azithromycin has been used successfully in other chronic lung diseases, including cystic fibrosis. Despite limited clinical evidence, some pediatricians use azithromycin in children hospitalized with asthma, citing either treatment of atypical pathogens or its proposed anti-inflammatory properties. This study proposes a clinical trial to determine if azithromycin will shorten length of stay in children hospitalized with acute asthma exacerbations.

Who is eligible to participate?

Inclusion Criteria: - 4-12 years of age - Admission diagnosis of asthma at the Children's Hospital at Montefiore - History of persistent asthma (as defined by National Heart, Lung, and Blood Institute) Exclusion Criteria: - Concurrent bacterial infection requiring antibiotics - Antibiotics received within previous 2 weeks - Contraindication to azithromycin (including allergy to macrolides) - Chronic lung disease other than asthma (including bronchopulmonary dysplasia, cystic fibrosis, bronchiectasis) or home oxygen requirement - Immunodeficiency (primary or acquired) - Chronic systemic steroid use - Invasive or non-invasive mechanical ventilation required acutely as result of current asthma admission - Significant cardiac co-morbidity (including hemodynamically significant cardiac disease or arrhythmia) - Liver disease (hepatitis) - Pregnancy - Seizure disorder, currently on anti-epileptic medication) - Receiving albuterol every 4 hours (q4h) at the time of enrollment - Previous enrollment in study

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AzithromycinAzithromycin suspension (200mg/5mL)

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Azithromycin suspensionAzithromycin suspension at 10mg/kg/dose (max 500mg) Once daily for 3 days

Placebo suspensionSame volume as active drug Once daily for 3 days

Study Status

Completed

Start Date: October 2013

Completed Date: June 1, 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Length of Stay

Secondary Outcome: Readmission rate

Study sponsors, principal investigator, and references

Principal Investigator: Lindsey C Douglas, MD

Lead Sponsor: Montefiore Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02003911

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